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Conferring a Federal Property Right in Genetic Material: Stepping into the Future with the Genetic Privacy Act

Published online by Cambridge University Press:  24 February 2021

Michael M.J. Lin*
Affiliation:
University of California, Berkeley, Boston University School of Law

Extract

“A wise man can hear profit in the wind.”

—Pel, quoting the Ferengi Rules of Acquisition

The expansive biotechnology field includes many facets of medical research, from drug discovery and design, to gene therapy and the diagnosis of genetic diseases, to the use of deoxyribonucleic acid (DNA) evidence to identify individuals and genetic characteristics. The biotechnology industry requires a readily available supply of biological raw materials; much of current research is founded on cells, tissues, organs, fetal tissues and placentas, and other samples derived from human donors. However, this growing need for raw materials presents many economic, social, and ethical issues to society, researchers, and the existing legal regime. Furthermore, because courts and legislatures fail to provide a clear national rule regarding biological materials, the resulting legal uncertainties chill research and investment. Although very few cases address property rights in a person’s organs, tissues, and genetic material, the issues of autonomy and privacy involved evoke analogies to deep-seated issues such as slavery, the freezing of embryos, and abortion.

Type
Notes and Comments
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 1996

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References

1 Ferengi Rules of Acquisition, No. 22, available at http://www.cdsnet.net/vidiot/st-ds9/rules.html.

2 In this Note, biotechnology refers to any technique that uses living cells, tissues, or genetic material to create, improve, or “develop micro-organisms for specific uses—including . . . techniques such as gene cloning and cell fusion.” Office of Technology Assessment, U.S. Congress, New Developments in Biotechnology: Ownership of Human Tissues and Cells- Special Report, OTA-BA-337, at 24 (1987)Google Scholar [hereinafter OTA Report]; see also Karen G. Biagi, Moore v. Regents of the University of California: Patients, Property Rights, and Public Policy, 35 St. Louis U. L.J. 433, 438 n.47 (1991) (“Biotechnology is the use of living organisms, or of substances obtained from living organisms to make products of value to man.”) (citation omitted).

3 See, e.g., Carey, John, Swapping a Test Tube for a Shotgun, Bus. Wk., Sept. 18, 1995, at 116Google Scholar.

4 See, e.g., Lawler, Andrew & Stone, Richard, FDA: Congress Mixes Harsh Medicine, 269 Science 1038 (1995)CrossRefGoogle ScholarPubMed.

5 See, e.g., Nash, J. Madeleine, To Know Your Own Fate; A Test for Early Alzheimer’s Disease May Create a Dilemma for Patients Unless Treatments Are Found, Time, Apr. 3, 1995, at 62Google Scholar.

6 For example, police and other agencies collect deoxyribonucleic acid (DNA) for use in DNA- identification in criminal cases and for the identification of bodies. See Annas, George J., Privacy Rules for DNA Databanks: Protecting Coded ‘Future Diaries,’ 270 JAMA 2346, 2347 (1993)CrossRefGoogle ScholarPubMed (describing the use of DNA fingerprinting as physical evidence).

7 Genetic screening for cystic fibrosis, potential for breast cancer, Alzheimer’s disease, and many other genetic diseases and traits is currently available or being developed. Chase, Marilyn, Health Journal, Genetic Testing Needs Clear Plans for How to Handle Treatment, Wall St. J., Feb. 26, 1996, at B1Google Scholar.

Genes are the individual “pieces" of genetic material, which when connected, form the complete DNA strand. See OTA Report, supra note 2, at 41. In human DNA, there exist many thousands of genes, linked together by noncoding (junk) regions. See Watson, James et al., Molecular Biology of the Gene 627-29 (4th ed. 1987)Google Scholar.

8 See Moore v. Regents of the Univ. of Cal., 793 P.2d 479, 494 (Cal. 1990), cert. denied, 499 U.S. 936(1991).

9 See, e.g., Life Patenting Moratorium Act of 1993, S. 387, 103d Cong., 1st Sess. § 2(1) (1993) (proposing a two-year moratorium on the patenting of certain human tissues, organs, cells, and animal organisms, in order to allow Congress time to examine the issues raised). This bill, or forms of it, has been introduced in each congressional session, in both houses, since 1990, but never passed both the House and the Senate. See H.R. 730, 103d Cong., 1st Sess. (1993) (proposing the establishment of a National Center for Biological Resources to assist research, development, and conservation of biological resources).

10 See House Comm. on Gov't Operations, 16th Report of the Committee on Government Operations, 102d Cong., 2d Sess. 25 (1992) (citing the need for independent policy review for the Human Genome Project); Rowland, Bertram I., Legal Implications of Letter Licenses for Biotechnology, 1 High Tech. L.J. 99, 129 (1986)Google Scholar (“The ultimate result is that commerce will proceed cautiously in an area of substantial legal uncertainty.”).

11 Biagi, supra note 2, at 433 n.4.

12 Davis v. Davis, 842 S.W.2d 588 (Tenn. 1992), petition for reh'g denied in part and granted in part, 1992 Tenn. LEXIS 622 (Tenn. Nov. 23, 1992) (not for publication).

13 793 P.2d 479 (Cal. 1990), cert. denied, 499 U.S. 936 (1991).

14 Id. at 488-89.

15 Id. at 496.

16 See, e.g., Miles, Inc. v. Scripps Clinic and Research Found., 810 F. Supp. 1091 (S.D. Cal. 1993) (recognizing a property right in a cell line); Complaint, Hoffman-LaRoche, Inc. v. Golde, No. C-80-360I-AJZ (N.D. Cal. filed Sept. 11, 1980) (asking for a declaratory judgment with respect to property rights in a cell line); United States v. Arora, 860 F. Supp. 1091, 1098 (D. Md. 1994), aff'd, 56 F.3d 62 (4th Cir. 1995) (implying that “[Moore may be] subject to challenge on [its] own terms”).

17 See Genetic Privacy Act § 2(a)(8) (1995) [hereinafter GPA] (drafted by George J. Annas, J.D., M.P.H., Leonard H. Glantz, J.D., and Patricia A. Roche, J.D.) (manuscript available on request from Health Law Dep't of the Boston University School of Public Health, 80 Concord St., A-509, Boston, MA 02118, or by downloading from http://www-busph.bu.edu/Depts/HealthLaw/) (citing the need for uniform collection, storage, and use rules for DNA samples to protect individuals and pro mote legitimate research). Department of Energy grant no. DE-FG02-93ER61626 supported this bill. Id. (page before Table of Contents).

18 See id. § 104(a). The authors submitted this bill to Congress in 1995. On November 15, 1995, Senator Mark O. Hatfield (R-Or.) introduced a version of this bill, entitled the Genetic Privacy and Nondiscrimination Act of 1995, whereupon Congress referred it to the Senate Labor and Human Resources Committee. S. 1416, 104th Cong., 1st Sess. (1995). On November 29, 1995, Representative Clifford B. Sterns (R-FIa.) introduced the same bill in the House of Representatives, which referred it to the House Committees on Commerce, Economic and Educational Opportunities, and Government Reform and Oversight. H.R. 2690, 104th Cong., 1st Sess. (1995).

19 See GPA, supra note 17, § 104(a) (establishing a source’s property interest in “individually identifiable DNA”). The GPA confers to the source of the DNA a protectable property interest in the DNA itself. Id.

The very immutability of genetic information makes it extremely susceptible for use in targeting individuals. For example, some genetic markers indicate potential likelihood of contracting certain diseases. See Annas, supra note 6, at 2348; Chase, supra note 7 (describing “molecular augury’s" power to find disease genes from blood). Furthermore, cases like Moore are distinguishable from cases involving frozen gametes. Hecht v. Superior Court, 20 Cal. Rptr. 2d 275, 280 n.4 (Ct. App. 1993) (distinguishing Hecht from Moore, both procedurally and factually; Hecht concerned the ownership of decedent’s frozen sperm).

20 In this Note, genetic material refers to DNA, or ribonucleic acid (RNA) capable of passing on or expressing genetic information. The OTA Report defines DNA as: "The molecule that is the repository of genetic information in all organisms [except certain viruses]. . . .” OTA REPORT, supra note 2, at 157. RNA is defined as: "A molecule . . . responsible for translating the genetic information encoded by an organism (i.e., DNA) into a protein product; the hereditary material of some viruses.” Id. at 158.

21 In this Note, cell lines refer to cells capable of perpetual replication which produce a cell- product (usually a protein). Watson et al., supra note 7, at 936. Usually these cells are formed by genetically combining a cancerous cell (capable of perpetual replication) with a “normal" cell which expresses the desired gene. OTA Report, supra note 2, at 5. Because normal cells have a limited replication cycle, the union of the two cells can produce a cell line which produces the protein in definitely. See id.; Darnell, James et al., Molecular Cell Biology 172 (2d ed. 1990)Google Scholar (describing the fusion of lymphocytes with immortal mylenoma cells to produce immortal hybridoma cells). The OTA Report defines a cell line as: "A sample of cells that has undergone the process of adaptation to artificial laboratory cultivation and is capable of sustaining continuous, long- term growth in culture.” OTA Report, supra note 2, at 156.

Cell lines comprise patentable subject matter under 35 U.S.C.A. § 101 (West 1984), as recognized by the United States Patent and Trademark Office, as well as the courts in Moore and Miles.

22 See case discussions infra parts II.A-D.

23 See OTA Report, supra note 2, at iii. As the Foreword to the OTA Report notes, the entire field began in the 1970s. Id.

24 Id. at31.

25 793 P.2d 479 (Cal. 1990), cert. denied, 499 U.S. 936 (1991).

26 For an in-depth compilation of arguments for and against the recognition of property rights in “extracorporeal" body parts, see Sharon Nan Perley, Note, From Control over One’s Body to Control over One’s Body Parts: Extending the Doctrine of Informed Consent, 67 N.Y.U. L. REV. 335, 337 n.13 (1992).

Furthermore, in United States v. Arora, the United States District Court for the District of Maryland distinguished Moore and implied that it may be “subject to challenge [on its] own terms.” 860 F. Supp. 1091, 1098 (D. Md. 1994). The Arora court quoted the dissenting opinion of Justice Broussard in support of its decision. Id. The court stated that if the cells had been stolen from the University of California at Los Angeles (UCLA) Medical Center and used, there would be no question that an action for conversion exists. Id.; see also Moore, 793 P.2d at 506 (Broussard, J., concurring and dissenting).

27 793 P.2d at 496-97. The California Supreme Court indicated that Mr. Moore’s claims stated an action for breach of fiduciary duty, not an extension of the doctrine of conversion. Id. at 497. In addition, the court suggested that the legislature is better equipped to tackle this issue. Id. at 496.

28 Id. at 479; Howard, John J., Biotechnology, Patients’ Rights, and the Moore Case, 44 Food Drug Cosm. L.J. 331, 333 (1989)Google ScholarPubMed.

Because of the procedural posture of Moore, the California Supreme Court assumed “that the complaint’s properly pleaded allegations are true and give the complaint a reasonable interpretation by reading it as a whole and all its parts in their context.” Moore, 793 P.2d at 480; see also Howard, supra, at 334, 350-52; Helen R. Bergman, Case Comment: Moore v. Regents of the University of California, 18 Am. J.L. & Med. 127, 129-31 (1992).

29 Moore, 793 P.2d at 481. In Mr. Moore’s case, his cancerous blood cells possessed T- lymphocyte features, only the second such occurrence in recorded medical literature. Saxon, Andrew et al., T-Lymphocyte Variant of Hairy-Cell Leukemia, 88 Annals Internal Med. 323, 325 (1978)CrossRefGoogle ScholarPubMed (describing John Moore’s condition and his pathological and clinical features).

30 Moore, 793 P.2d at 481; see also Howard, supra note 28, at 350-51 n.!61 (noting that approximately 80 percent of hairy-cell leukemia patients undergo splenectomies).

31 Moore, 793 P.2d at 481.

32 Id.

33 Id.

34 Id.

35 Bergman, supra note 28, at 130.

36 U.S. Patent No. 4,438,032. Moore’s cells produced a wide variety and continuous supply of cell proteins. See id.

37 Moore, 793 P.2d at 482.

38 Id.

39 Id. Estimate in 1990 dollars. Id.

40 Bergman, supra note 28, at 130.

41 Moore v. Regents of the Univ. of Cal., 249 Cal. Rptr. 494, 498 (Ct. App. 1988). Ironically, in a prior suit, in Defendant’s Answer and Counterclaim, Hoffman-LaRochc requested a declaratory judgment stating that the University of California and Dr. Golde possessed neither a property interest in a separate cell line, nor any other claims against Hoffman-LaRoche. Rowland, supra note 10, at 100-02 (citing Hoffman-LaRochc, Inc. v. Golde, No. C-80-3601-AJZ (N.D. Cal. filed Nov. 14, 1980)). The University of California counterclaimed on theories of misappropriation and conversion. Id. at 101. The parties reached an amicable settlement, and thus the case never received judgment on its merits. Id. at 102.

42 Moore, 249 Cal. Rptr. at 501.

43 Id. at 502-03.

44 Id. at 505.

45 Id. at 502.

46 Moore v. Regents of the Univ. of Cal., 793 P.2d 479, 485 (Cal. 1990), cert. denied, 499 U.S. 936 (1991). The court found that Golde failed to disclose his economic and research interests and to obtain informed consent for the medical procedures involved in extracting Moore’s cells. Id.

47 Id. at 497.

48 Id. at 489.

49 Id. at 487, 491, 493-94.

50 Id. at 496. The California Supreme Court denied Moore’s request for a rehearing on August 30, 1990. Moore v. Regents of the Univ. of Cal., 1990 Cal. LEXIS 3975 (Cal. Aug. 30, 1990). The Supreme Court denied Moore’s petition for certiorari in 1991. Moore v. Regents of the Univ. of Cal., 499 U.S. 936(1991).

51 See, e.g., Miles, Inc. v. Scripps Clinic and Research Found., 810 F. Supp. 1091 (S.D. Cal. 1993); United States v. Arora, 860 F. Supp. 1091 (D. Md. 1994).

52 Miles, 810 F. Supp. at 1092. Scripps-Miles was a joint research venture between Miles, a pharmaceutical company, and Scripps, a nonprofit research foundation. Id. Dr. Zimmerman served as a diagnostic immunology consultant. Id.

53 Id. at 1093. The cell line at issue produces antibodies used in a process for purifying Factor VIII:C. Id. Factor VIII:C allows hemophiliacs* blood to clot and does not carry the risk of disease transmittal that other treatments pose. Id.

54 Id.

55 Id.

56 Id. Here, the cell line itself is not at issue, but rather the “right to commercialize" the cell line. Id. at 1093 n.3.

57 Id. at 1093.

58 Id. (discussing Miles, Inc. v. Scripps Clinic and Research Found., 951 F.2d 361 (9th Cir. 1991) (unpublished disposition)).

59 Id. at 1095-96.

60 Id. at 1096 (emphasis added).

61 Id. at 1097.

62 Id. at 1096.

63 Id. at 1098.

64 Id.

65 Id. at 1100.

66 Id. at 1102.

67 OTA Report, supra note 2, at 26; Sherman, Rorie, The Selling of Body Parts, Nat'l L.J., Dec. 7, 1987, at 1Google Scholar; Sun, Majorie, Scientists Settle Cell Line Dispute: But Question of Claiming Ownership Based on Family Ties to Cell Donor is Sidestepped, 220 Science 393 (1983)CrossRefGoogle Scholar.

68 Sun, supra note 67, at 393 (noting that the case settled out of court).

69 Id.

70 Id at 393-94.

71 See id. at 394.

72 Id. at 393-94. In an interesting twist, Dr. Hagiwara’s father, also a physician, owned a Japanese drug company interested in selling the products derived from the cell line. OTA Report, supra note 2, at 26.

73 OTA Report, supra note 2, at 26.

74 Sun, supra note 67, at 393.

75 See OTA REPORT, supra note 2, at 26.

76 ld.; Sun, supra note 67, at 394.

77 United States v. Arora, 860 F. Supp. 1091, 1093 (D. Md. 1994).

78 Id.

79 Id. Receptors are cell membrane proteins which often act as triggers to “cascade effects" within the cell, usually possess very specific binding characteristics, and specifically trigger only certain cell reactions. Darnell et al., supra note 21, at 711. The team developing the cell line did not include Dr. Arora. Arora, 860 F. Supp. at 1093.

80 Arora, 860 F. Supp. at 1094.

81 Id. Researchers often grow cell lines and cultured cells in sterile glass or plastic flasks that contain a growth media. OTA Report, supra note 2, at 32-33.

82 Arora, 860 F. Supp. at 1094. Reasonable explanations for the massive cell deaths reported include, among others, contamination of the growth media and a faulty incubator. Id.

83 Id.

84 Id.

85 Id.

86 Id.

87 Id. at 1095. β-mercaptoethanol (also known as 2-mercaptoethanol) is a chemical which is capable of killing the cells at issue, even in concentrations as low as .01%. Id.

88 Detective Miller and Captain Picket both testified that Arora admitted to adding the β- mercaptoethanol to the flasks. Id. at 1095-96. Arora denied this admission. Id.

89 Id. at 1097. In the suit, the United States sought compensatory and punitive damages from Dr. Arora. Id. at 1096.

90 Id. at 1097 (stating that trespass constitutes interference with another’s chattel, while con version represents the exercise of dominion or control).

91 Id. at 1099. The court assessed fines of $450.20 in compensatory damages and $5000 in punitive damages against Dr. Arora. Id. at 1101.

92 Id. at 1098.

93 Id.

94 Id.

95 Id.

96 Id.

97 Id.

98 See, e.g., supra note 26 and accompanying text.

99 See, e.g., Moore v. Regents of the Univ. of Cal., 793 P.2d 479, 507 (Cat. 1990) (Mosk, J., dissenting) (citation omitted), cert. denied, 499 U.S. 936 (1991); Howard, supra note 28, at 352-53 (discussing the Moore Court of Appeals decision).

100 See infra part III.A.

101 See OTA Report, supra note 2, at 83-84. The twin doctrines of accession and specification closely analogize to the situation in the Moore case. See infra notes 113-17 and accompanying text.

102 See infra notes 118-25 and accompanying text.

103 Mortinger, Stephen Ashley, Comment: Spleen for Sale: Moore v. Regents of the University of California and the Right to Sell Parts of Your Body, 51 Ohio St. L.J. 499, 504 (1990)Google Scholar (examining the expansion and checks to property rights in bodies, excrement, blood, and body parts).

104 See Danforth, Mary T., Cells, Sales, and Royalties: The Patient’s Right to a Portion of the Profits, 6 Yale L. & Pol'y Rev. 179 (1988)Google ScholarPubMed.

105 See Moore v. Regents of the Univ. of Cal., 793 P.2d 479, 507 (Cal. 1990) (Mosk, J., dissenting) (citation omitted), cert. denied, 499 U.S. 936 (1991).

106 Id. at 496 n.41; see also id. at 503-04 (Broussard, J., concurring and dissenting).

107 See generally id. There is no doubt that Moore “owned" the cells while they were in his body. See id. at 499. While the California Supreme Court relics on abandonment theory and a statutory basis to show relinquishment of Moore’s property rights, see id. at 488-89, the situation is closely analogous to the con man acting as a real estate agent who fraudulently persuades people to sign over their houses. Even if there exists a reason for them to move (analogizing to Moore’s need for an operation), the con man cannot claim, once the house is signed over, that the ex-homeowner has abandoned all property rights therein. Thus, I believe that fraud in this instance stands alone as a method of recovery, independent of an action for conversion.

For a criticism that the California Supreme Court itself denied Moore his property rights in the excised materials, see Laura M. Ivey, Case Comment, Moore v. Regents of the University of California: Insufficient Protection of Patients’ Rights in the Biotechnological Market, 25 Ga. L. Rev. 489, 515-17 (1991).

108 For a discussion of the right of commercialization, see Miles, Inc. v. Scripps Clinic and Research Found., 810 F. Supp. 1091, 1096 (S.D. Cal. 1993).

109 Id. at 1095. For a famous case involving the right of publicity, see White v. Samsung Elecs. Am., Inc., 971 F.2d 1395 (9th Cir. 1992) (involving an advertisement utilizing a depiction of a robot imitation of Vanna White).

110 The right to commercialize, as espoused by Howard, supra note 28, at 343.

111 The Miles court accepted the right-to-commercialize argument, finding that the plaintiff possessed a property interest in the cell line itself. Miles, 810 F. Supp. at 1095. However, the court refused to accept that California law protected this intangible property right from conversion. Id. The court did not explicitly address the conversion of DNA, but instead focused on the cell line itself.

The court in Arora accepted the right-to-commercialize argument and held that a cell line is a chattel capable of being converted. United States v. Arora, 860 F. Supp. 1091, 1099 (D. Md. 1994).

112 Cf. Moore v. Regents of the Univ. of Cal., 793 P.2d 479, 501 (Cal. 1990) (Broussard, J., concurring and dissenting) (implying that no need for extension of conversion is required because Moore’s complaint states a cause of action under traditional, common law conversion), cert. denied, 499 U.S. 936(1991).

113 See OTA Report, supra note 2, at 83-84.

114 Id.

115 Id.

116 1 C.J.S.Accession § 2 (1985).

117 OTA Report, supra note 2, at 83-84.

118 Restatement (Second) of Agency § 381 (1957).

119 Id. § 388; see also id. cmt. a. With respect to Moore, if his attending physician, Dr. Golde, acted as his agent, there existed an additional duty for the agent to refrain from acting adversely to the principal’s interests. Id. § 389. If, as alleged, Golde did anything unnecessary for Moore’s treatment for hairy-cell leukemia, or adverse to Moore’s interests, such as making him incur unnecessary travel expenses, tests, or painful procedures, such as bone marrow extractions, then Golde would be liable for damages.

120 See id. § 389 cmt. c (noting that the section applies when the agent engages in self-dealing, irrespective of any actual harm to the principal).

121 Id.

122 See generally id. cmt. b (stating that unless otherwise agreed, an agent acting adversely to the principal is under a duty to disclose all material facts and to deal fairly with the principal); see also id. § 390.

123 See id. § 7 (discussing the authority granted to the agent); id. § 7 cmts. a-c (discussing the scope of the authority granted by the principal to the agent).

124 See id. § 389 cmt. a.

125 The author greatly appreciates the generous help of Professor Stephen Marks, Boston University School of Law, for his assistance in formulating this theory regarding the application of agency principles to the doctor-patient relationship.

126 See Danforth, supra note 104, at 195-201.

127 Broadcast Music, Inc. v. Columbia Broadcasting Sys., 441 U.S. 1, 5 (1979).

128 Id at 21.

129 Id.

130 See id. at 22-23.

131 Id. at 22 n.40.

132 Id. at 23. For example, the transaction costs of having each individual artist negotiate con tracts with mass-media entities becomes immensely prohibitive; ASCAP created a market whereby such mass-media entities could purchase, in one step, access to thousands of compositions and sound bytes. See id. at 22-23.

133 See id. at 20.

134 See id. at 22 n.40 (noting that popular songs receive an increased share of the royalties).

135 OTA Report, supra note 2, at 55.

136 With respect to medical malpractice, the standard of care is the “minimally sound medical judgment and . . . minimally competent care" that is “required by law.” Hall v. Hilbun, 466 So. 2d 856, 866 (Miss. 1985). Thus, Moore’s allegations that some of the procedures that Dr. Golde under took only benefited the research project and had no bearing on Moore’s treatment become relevant in an action for malpractice. See id. If Golde conducted tests or procedures beyond those medically necessary for Moore’s condition, or went outside the range of acceptable treatment for his condition, then Golde would be liable in a malpractice suit. See id.

Furthermore, while Moore granted consent for the initial splenectomy, his consent with regard to the follow-up procedures remains in doubt. See supra notes 32-40 and accompanying text.

137 Conflicts of interest can taint a physician-researcher’s medical judgment. See, e.g., Moore v. Regents of the Univ. of Cal., 793 P.2d 479, 484 (Cal. 1990), cert. denied, 499 U.S. 936 (1991). A physician’s fiduciary duty to a patient supposedly addresses this, but other incentives may be necessary to insure compliance. A breach of fiduciary duty may be punished by a nominal sanction, as compared to the potential to share in millions of dollars of royalties. See Hartman v. D'Ambrosia, 665 So. 2d 1206, 1207 (La. Ct. App. 1995) (noting that the trial court fixed plaintiffs damages for breach of fiduciary duty at $25,000). Also, it is conceivable that results such as Moore provide researchers with an incentive to “gamble" that donors will never discover that their raw materials were used. See lvey, supra note 107, at 530 (hypothesizing that medical researchers may “cost out" their liability). Given the choice, I believe that certain physician-researchers may “take the chance" to gain exorbitant profits, rather than to bother with informing the patient, obtaining consent, and sharing the possible profits. See id. The court’s holding in Moore appears to tempt doctors to breach their duty to disclose, if there exists any significant chance that the patient-donor would ref use to give permission for the procedure or prohibit the use of her bodily substances.

138 See, e.g., Bergman, supra note 28, at 143-45 (proposing two legislative changes; first, a change to National Organ Transplant Act (NOTA) to explicitly prohibit the sales of tissues and cells and second, a model informed consent rule).

139 See, e.g., id. at 136-37 (examining NOTA’s prohibition on the sale of organs).

140 See, e.g., Moore, 793 P.2d at 489 (footnotes omitted) (citing California’s adoption of the Uniform Anatomical Gift Act and health and safety codes permitting adults to donate organs, blood, fetuses, pituitary glands, corneal tissue, and dead bodies for science or transplantation); see also NOTA, 42 U.S.C.A. §§ 273-274c (West Supp. 1994).

141 See, e.g., OTA Report, supra note 2.

142 See, e.g., Haw. H.B. 1556, 18th State Leg. (1995) (prohibiting insurers from requesting or requiring genetic testing and further prohibiting insurers from determining rate structures according to the results of genetic testing); N.Y.A.B. 5796, 219th Gen. Assembly, 2d Reg. Sess. (1995) (addressing confidentiality of genetic records and penalties for unauthorized disclosure); Okla. H.B. 2478, 45th Legis., 2d Sess. (1996) (creating the Genetic Privacy and Nondiscrimination Act, which addresses use of genetic information for insurance purposes and penalties for unauthorized use); Wis. S.B. 182, 92d Legis. Sess. (1995-96) (addressing registration, collection, and analysis of DNA samples from violent sexual offenders). For state legislative responses adressing protection of genetic information in the context of health insurance, see Rothenberg, Karen H., Genetic Information and Health Insurance: State Legislative Approaches, 23 aJ.L. Med. & Ethics 312 (1995)Google ScholarPubMed.

143 See Or. Rev. Stat. § 659.705(1)(e) (1995). For example, legislative findings in this bill state that “[c]urrent legal protections for medical information, tissue samples and DNA samples are inadequate to protect genetic privacy.” Id.

144 See id.

145 Oregon Bill Tracking Statenet, Or. S.B. 276, 68th Legis. Assembly (1995), available in LEXIS, Legis Library, TRCK95 File (codified at OR. REV. STAT. §§ 659.036, 659.227, 659.700- .720,746.135(1995)).

146 Or. Rev. Stat. § 659.705(2).

147 Id. §659.710(1).

148 Id. § 659.710(1)(a)-(e).

149 Id. § 659.710(2)-(3).

150 Id. § 659.715(1)-(2).

151 Id. § 659.715(2)(a)-(d).

152 Id. § 659.715(3).

153 Id. § 659.715(4).

154 Id. § 659.715(5).

155 Id. § 659.715(6).

156 Id. § 659.715(8).

157 Id. § 659.720(1).

158 Id. These exceptions parallel the exceptions to the general rule of collection, described in § 659.710 of the Oregon Law. Compare id. § 659.710 with id. § 659.720.

159 Id. § 659.036(1) (allowing testing for bona fide objectives).

160 Id. § 659.036(2).

161 Id. § 659.227(6).

162 Id. §746.135.

163 Id. § 746. 135(1)-(3). For example, even if an insurer receives permission to conduct genetic tests, the Oregon Law prohibits the insurer from using that information to reject applicants, or otherwise affect their policies. See id. § 746.135(3).

164 New York Bill Tracking Statenet, N.Y.S.B. 3118, 219th Gen. Assembly, 2d Reg. Sess. (1995), available in LEXIS, States Library, NYTRCK File, and New York Bill Tracking Statenet, N.Y.A.B. 5227, 219th Gen. Assembly, 2d Reg. Sess. (1995), available in LEXIS, States Library, NYTRCK File [hereinafter New York Bill]. For related New York bills addressing the issue of protection of genetic information, see N.Y.A.B. 5796; N.Y.A.B. 7839, 218th Gen. Assembly, 1st Reg. Sess. (1995).

165 N.Y.S.B. 3118, § 2. In the context of the New York Bill, genetic testing refers to “medical and biological examination and analysis of a person to determine the presence and composition of genes . . . includ[ing] DNA profile analysis.” Id. § 1.

166 See, e.g., Ind. H.B. 1200, 109th Gen. Assembly, 2d Sess. (1996); Pa. S.B. 394, I79th Gen. Assembly, Reg. Sess. (1995-96).

167 N.Y.S.B. 3118, §2.

168 Cf. Pa. S.B. 394 (concentrating on protections provided by the informed consent doctrine); Or. Rev. Stat. § 659.700-.720 (granting a property interest in genetic information, but also relying on the doctrine of informed consent).

169 N.Y.S.B. 3118, §2.

170 Id. § 3. Section 3 of the New York Bill exempts information regarding individuals who are subject to a criminal investigation. Id.

171 Pennsylvania Bill Tracking Statenet, Pa. S.B. 394, 179th Gen. Assembly, Reg. Sess. § 2 (1995-96), available in LEXIS, States Library, PATRCK File (referred to the Senate Committee on Public Health and Welfare, February 2, 1995).

172 Pa. S.B. 394, § 4(a).

173 Compare id. § 4(b) with Or. Rev. Stat. § 659.710(1) (both allowing tests for identification purposes, criminal cases, and where the identity of the individual will not be revealed). The Pennsylvania Bill also includes the use of human cadavers for research and emergency conditions where consent is unavailable. Pa. S.B. 394, § 4(b)(1), (4).

174 Pa. S.B. 394, § 5(a).

175 Id. § 5(b).

176 See id. § 5(c)-(d).

177 Id. § 5(e).

178 Id. §§ 6-7.

179 Id. § 8.

180 See generally Or. Rev. Stat. §§ 659.036, 659.227, 659.700, 746.135. The only right granted to donors is the right to order destruction of the samples. See id. § 659.715(3).

181 Moore v. Regents of the Univ. of Cal., 793 P.2d 479, 510 (Cal. 1990), cert. denied, 499 U.S. 936(1991).

182 Id. at 494 (citation omitted).

183 See generally id. at 484.

184 Id.

185 Cobbs v. Grant, 502 P.2d 1, 9 (Cal. 1972).

186 Moore, 793 P.2d at 484 n.8.

187 H.R. 2690, 104th Cong., 1st Sess. (1995) and S. 1416, 104th Cong., 1st Sess. (1995) [hereinafter GPNA]. House Bill 2690 and Senate Bill 1416 are identical, except for their respective Houses in Congress and sponsors. Compare H.R. 2690 with S. 1416.

188 GPNA, supra note 187. § 2(b).

189 Id. §4.

190 Id.

191 See id. § 4(a)(2)(A)-(E).

192 Id §§ 5-6.

193 Id. § 5(b).

194 Id.

195 See id. § 6 (“[Prohibiting the use of] genetic information to reject, deny, limit, cancel, refuse to renew, increase the rates of, or otherwise affect health insurance.”). Id. § 6(a).

196 Id. §6(c).

197 Id. §7.

198 Id.

199 See Science Council of Can., Social Issues in Human Genetics: Genetic Screening and Counseling 97 (1980)Google Scholar (presenting the interests which must be taken into account in formulating genetic policies).

200 See Moore v. Regents of the Univ. of Cal., 793 P.2d 479, 483 (Cal. 1990), cert, denied, 499 U.S. 936 (1991) (stating that physicians must disclose personal interests which may affect their judgment). This is most prevalent in Mr. Moore’s case, but the prevention of conflicts of interest as a general theme is for the public good. See id. at 483-84 (discussing state statutes requiring the disclosure of conflicts of interest) (citations omitted).

201 See Annas, supra note 6, at 2349 (citing a need for databanks to adopt voluntary rules). The atmosphere of legal uncertainty is sure to hinder research and investment in the industry. See supra note 10 and accompanying text.

202 See generally OTA Report, supra note 2, at 3 (discussing using biological materials to develop products for diagnostic, therapeutic, and research uses). The benefits derived from the expanding biotechnology field include treatments for cystic fibrosis, immune suppressing and activating drugs, diabetes treatments, and many other treatments and pharmaceuticals which greatly enhance health and quality of life. See id.; see also Chase, supra note 7, at B1. Currently, companies possess financial incentives to pursue these goals and any proposed rule must take this societal interest into account when balancing the rights of individuals. See OTA Report, supra note 2, at 63 (discussing the many parties now possessing an interest in human biological materials).

203 Moore v. Regents of the Univ. of Cal., 793 P.2d 479 (Cal. 1990), cert. denied, 499 U.S. 936 (1991).

204 Miles, Inc. v. Scripps Clinic and Research Found., 810 F. Supp. 1091 (S.D. Cal. 1993).

205 With the advent of polymerase chain reaction (PCR) and improved isolation processes, I believe a greater diversity of raw materials is more valuable than a greater volume of raw materials. PCR allows a scientist to replicate a single piece of DNA into many copies. Darnell et al., supra note 21, at 219.

206 See GPA, supra note 17, § 3(e). The GPA only addresses human DNA and the information contained therein. Id.

207 Id. §§ 101-105. Research is covered in § 131 of the Act, placing the burden on institutional review boards to assure that their charges meet all requirements of the Act. Id. § 131(a).

208 Id. §§ 111-115.

209 Id. §§ 171-172. Like the state bills analyzed, the GPA also contains exceptions to the general rule of consent, such as for identification purposes and criminal investigations. Id. §§ 121-123. Furthermore, the GPA contains provisions regarding minors, incompetents, pregnant women, fetuses, and extracorporeal embryos. Id. §§ 151-153. For purposes of this Note, these provisions are viewed as ancillary to the three central portions of the GPA discussed in the text.

210 Id. § 101(a).

211 Id. § 103(a).

212 Id. § 103(a)(8). This provision also controls uses of the sample if it later becomes “unidentified.” Id.

213 See id.

214 Moore v. Regents of the Univ. of Cal., 793 P.2d 479, 520 (Cal. 1990) (Mosk, J., dissenting), cert. denied, 499 U.S. 936 (1991).

215 GPA, supra note 17, § 103(c).

216 Id. § 103(b).

217 See id.

218 Note also that the Act does not purport to grant an exclusive right in all DNA that one possesses. Most human DNA is the same, and the differences between individuals is extremely minute. Dunn, Robert S., The Power of DNA Evidence; ‘Trial of the Century’ Illuminates Issue, N.Y.L.J., July 17, 1995, at S1Google Scholar (“99 percent of all human DNA is identical, in the remaining 1 percent, there exists numerous loci or sites wherein variation can be detected.”); Wronko, James R., What Litigators Should Know About DNA Testing, N.J. Law., May 1, 1995, at 15Google Scholar (“DNA varies little from one person to the next . . . .”). If Congress passes the GPA, then presumably, concurrent ownership to “human" DNA exists, but the DNA from any specific sample remains the property of the sample source, as long as it falls under the definition of “private genetic information.” See GPA, supra note 17, § 3(m) (defining private genetic information).

While most property rights are state-created, the GPA grants a federal property interest. See id. § 104. Although rare, this federal property interest would not be anomalous or unique. Federal property rights exist in limited areas of intangible property, such as patents, copyrights, and trademarks. See, e.g., 35 U.S.C.S. § 261 (Law. Co-op. 1981) (“Patents shall have the attributes of personal property.”).

219 GPA, supra note 17, § 104(b). This right to order the sample’s destruction remains subject to limitations within the GPA itself, such as in criminal investigations, id. § 122, and where a court orders genetic analysis. Id. § 123.

220 Id. § 104(a).

221 Id § 3(n).

222 Id. § 3(i). The GPA only protects DNA whose source can be identified. See id. § 3(g)-(h). An identifiable person would be, for example, Mrs. Hagiwara or Mr. Moore. DNA whose source cannot be identified is not covered. See id. §§ 101(a), 102(a). Presumably, such DNA would then be within the public domain. This does not lead to an incentive to “lose" the identifying information for samples, as the GPA provides for notification to the sample sources as to the current status of their samples. See id. § 113 (providing for inspection of records). Furthermore, common law fraud covers intentional actions such as that described. See Black’s Law Dictionary 660 (6th ed. 1990) (describing fraud as “[a]n intentional perversion of truth for the purpose of inducing another in reliance on it to part with some valuable thing ... or to surrender a legal right”).

223 See Rowland, supra note 10, at 129.

224 See id.

225 Cf. Moore v. Regents of the Univ. of Cal., 793 P.2d 479, 495-96 (Cat. 1990), cert. denied, 499 U.S. 936 (1991). A major fear of the Moore court was that the granting of property rights to the plaintiff would greatly chill research and investment in the biotechnology industry, leading to an overall decrease in the availability of new drugs and treatments. Id.

226 For example, compare the incentives of Mr. Moore and Mrs. Hagiwara to participate in research. Mr. Moore could receive no possible (health) benefit from the experiments using his cells, while Mrs. Hagiwara’s life depended on her son’s research. The industry and researchers, on the other hand, possess many incentives to experiment: financial rewards, prestige, patent protection, and proprietary rights in new processes and pharmaceuticals. See, e.g., OTA Report, supra note 2, at 54-56.

227 See Moore, 793 P.2d at 520 (Mosk, J., dissenting). In Mr. Moore’s case, he did not benefit from the cell line at all. In fact, the argument exists that Golde greatly injured him, by invading his body, causing him to lose earnings and out-of-pocket expenses for his trips from Seattle to Los Angeles to provide Golde with samples. See id. at 481. If as alleged, some of the samples taken from Moore only benefited Golde and were unnecessary for treatment, then Moore possesses a much stronger malpractice claim. See Hall v. Hilbun, 466 So. 2d 856, 866 (Miss. 1985) (defining the duty of care). If, however, Moore in fact benefited from the treatments and Golde only conducted necessary tests, then Moore suffered no tangible “harm.” If a restitutionary basis in tort law is sought, then there may be no need for compensation, as the patient experiences no “harm.” Cf. supra note 185 and accompanying text (suggesting that recovery based on the duty to disclose is not dependent on harm to the plaintiff). For a further examination of the restitutionary basis for harm and its applicability to intellectual property and intangible property, see generally Wendy J. Gordon, of Harms and Benefits: Torts, Restitution, and Intellectual Property, 21 J. LEGAL STUD. 449 (1992). For an argument that Moore deserves no reward because he is unable to produce a cell line and is thus unable to fulfill the market niche, see generally Gordon, Wendy J., On Owning Information: Intellectual Property and the Restitutionary Impulse, 78 Va. L. Rev. 149 (1992)CrossRefGoogle Scholar.

228 See Judith B. Prowda, Moore v. The Regents of the University of California: An Ethical Debate on Informed Consent and Property Rights in a Patient’s Cells, 77 J. Pat. & Trademark Off. Soc'y 611, 631 (1995) (discussing patients’ financial and social incentives to allow research, once a property right is recognized) (citation omitted); see generally OTA Report, supra note 2, at 115 (denoting that arguments for payments for human biological materials have been debated for many years).

229 See Moore, 793 P.2d at 520 (Mosk, J., dissenting).

230 For example, the chances of successfully establishing a cell line vary greatly, ranging from .01% to almost 100%, depending on the type of cells used. See OTA Report, supra note 2, at 5. However, the probability of a successful economic result may often be very low. Nonmonetary results are even more difficult to quantify, such as the change in a researcher’s reputation after each scholarly publication, prestige issues, and publishing the first article on a ground-breaking discovery. Because reputation is so important in the research industry, it is impossible to separate non-monetizable benefits from pecuniary gain.

231 See GPA, supra note 17, § 104(a). This ownership interest effectively grants to patients an “affirmative right of participation" in commercial biotechnology research. See Howard, supra note 28, at 344.

232 See GPA, supra note 17, §§ 171-172.

233 Id. § 171. Actions for damages or equitable relief are provided. Id. § 171(a).

234 Id. § 171(a).

235 Id. § 171(b).

236 Id. § 171(a).

237 Id. § 171(a), (c)-(e).

238 Compare id. § 171(d) with id. § 171(e). For negligent violations of the Act, the monetary limit is actual damages or $25,000, whichever is greater. Id. § 171(d)(1). However, where the offender gained financially, the GPA provides for treble damages. Id. § 171(d)(2). Furthermore, where willful violations occur, the GPA permits actual damages or $50,000, whichever is greater, as well as punitive damages. Id. § 171(e).

239 Id. § 171(f)-(g).

240 Id. § 172.

241 Id.

242 Id.